产品与市场潜力 - NXC-201是针对复发/难治性AL淀粉样变病的唯一CAR-T疗法，目标市场为34,600名美国患者，市场价值为数十亿美元[6] - NXC-201的定价底线为每剂425,000美元，基于已建立的计费代码[6] - 目前没有FDA批准的药物用于复发/难治性AL淀粉样变病[21] - 约80%的复发/难治性AL淀粉样变病患者符合使用NXC-201的治疗资格[23] 临床试验与数据 - NXC-201的临床试验NEXICART-2的初步结果将在2025年ASCO会议上公布[9] - 预计NXC-201的临床数据将在2025年第二季度发布，随后进行BLA提交[9] - NXC-201在复发/难治性AL淀粉样变病患者中的中位CRS持续时间为1天，其他CAR-T疗法的CRS持续时间为4-8倍更长[32] - NEXICART-2试验中，10名患者中有7名实现完全缓解（CR），占比70%[49] - 所有10名患者在数据截止时均被分类为完全缓解或微小残留病（MRD）阴性（10^-6），预测未来的完全缓解[56] - NXC-201在复发/难治性AL淀粉样变患者中，dFLC（病理轻链）在治疗后的一个月内迅速正常化，符合国际数据集的结果[46] - NEXICART-2试验中，所有患者的中位神经毒性为0，且无ICANS神经毒性[54] - NXC-201在多发性骨髓瘤中的有效性表现为92%的总体反应率(ORR)和64%的完全反应率(CR)[90] 安全性与耐受性 - NXC-201的设计旨在提高耐受性，减少非特异性激活[11] - NXC-201在低容量疾病中的神经毒性为0%，而其他疗法的神经毒性为10-33%[29] - NXC-201的任何级别的细胞因子释放综合征(CRS)发生率为95%，而Abecma为85%[90] - NXC-201的神经毒性发生率为4%（均为1-2级），而Abecma为28%[90] - NXC-201的耐受性特征优越，无神经毒性且“单日细胞因子释放综合症”[133] 未来展望与研发 - 预计到2026年，NXC-201的临床试验将完成入组[9] - NEXICART-2试验中，1名患者出现5级感染，其他患者均未出现严重感染[53] - NXC-201的MRD阴性患者在48个月的无进展生存期(PFS)概率上表现优于MRD阳性患者[119] - MRD阴性患者在36个月的无进展生存率为88%[121] - NXC-201设计用于高效对抗导致AL淀粉样变的病理性浆细胞[129] 其他重要信息 - NXC-201的临床试验NEXICART-2计划在2025年第四季度/2026年第一季度完成患者招募[35] - NXC-201在复发/难治性多发性骨髓瘤患者中的有效率为4%，而其他疗法的有效率为23-28%[29] - 研究显示，心脏功能保存的患者的完全反应率为90%，而有既往心力衰竭的患者的完全反应率为50%[64] - NXC-201在30天内迅速消除病态游离轻链，显示出快速的治疗效果[60] - NXC-201的CD8铰链灵活性优化导致细胞因子释放减少超过90%[96]

Immix Biopharma, Inc. (IMMX) could be a solid choice for investors given its recent upgrade to a Zacks Rank #2 (Buy). An upward trend in earnings estimates -- one of the most powerful forces impacting stock prices -- has triggered this rating change.The Zacks rating relies solely on a company's changing earnings picture. It tracks EPS estimates for the current and following years from the sell-side analysts covering the stock through a consensus measure -- the Zacks Consensus Estimate.The power of a changin ...

– Selected to Attend In-Person Event on June 5 led by FDA Commissioner Marty A. Makary, M.D., M.P.H. – LOS ANGELES, CA, June 06, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that it was selected by FDA, and attended, the FDA CEO forum led by FDA Commissioner Marty A. Makary, M.D., M.P.H. and team at FDA headquarters in Silver S ...

Immix Biopharma (IMMX) Update / Briefing June 03, 2025 03:00 PM ET Speaker0 Thank you for joining us for this Key opinion leader event following ASCO twenty twenty five oral presentation of NXC two zero one Nexicar two trial interim results in relapsedrefractory AL amyloidosis that's just concluded. Here's the requisite disclaimers. And here's the agenda for today's event. First part will be led by doctor Raza who who'll share the unmet clinical need in relapsedrefractory AL amyloidosis and current treatmen ...

Immix Biopharma today presented results at ASCO from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201, meeting its primary endpoint. – NXC-201 met primary endpoint with a complete response (CR) rate of 70% (7/10 patients) – – No relapses recorded to-date; no safety signals identified – – Immix plans Biologics License Application (BLA) for FDA approval – – Results were presented by Heather Landau, MD, of Memorial Sloan Kettering Cancer Center – – KOL event to discuss significance Tuesda ...

– Patient enrollment exceeding expectations – – 14 U.S. sites actively enrolling; 10 U.S. sites added since last update – – Anticipate completing NEXICART-2 clinical trial ahead of schedule – LOS ANGELES, CA, May 23, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or "IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that 14 U.S. sites are actively enrolling in U.S. multi-site study ...

Immix Biopharma today reported ASCO abstract results from its U.S. multi-center NEXICART-2 Phase 1/2 clinical trial of NXC-201 demonstrating strong efficacy and favorable safety. – NXC-201 demonstrated a complete response (CR) rate of 71% (5/7 patients) – – No relapses recorded to-date; no safety signals identified – – Updated results with a later data cutoff, including endpoint analysis, will be presented at ASCO by lead investigator Heather Landau, MD, of Memorial Sloan Kettering Cancer Center – – KOL ev ...

– Virtual KOL Event Tuesday, June 3, 2025 3:00pm ET – – Attend the event here: https://lifescievents.com/event/immix-asco – LOS ANGELES, CA, May 21, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that it will host a virtual Key Opinion Leader (KOL) event to discuss interim clinical data from the NEXICART-2 Phase 1/2 clinical trial ...

UNITED STATES SECURITIES AND EXCHANGE COMMISSION WASHINGTON, DC 20549 (Exact Name of Registrant as Specified in its Charter) FORM 10-Q (Mark One) ☒ QUARTERLY REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the quarterly period ended March 31, 2025 OR ☐ TRANSITION REPORT PURSUANT TO SECTION 13 OR 15(d) OF THE SECURITIES EXCHANGE ACT OF 1934 For the transition period from _________to ___________ Commission File Number: 001-41159 IMMIX BIOPHARMA, INC. Delaware 45-4869378 (Stat ...

— Oral presentation Tuesday, June 3, 2025 in Chicago — LOS ANGELES, April 23, 2025 (GLOBE NEWSWIRE) -- Immix Biopharma, Inc. (“ImmixBio”, “Company”, “We” or “Us” or ”IMMX”), a clinical-stage biopharmaceutical company developing cell therapies for AL Amyloidosis and other serious diseases, today announced that Phase 1/2 interim readout data from its U.S. NXC-201 NEXICART-2 trial in relapsed/refractory AL Amyloidosis has been selected for oral presentation at the upcoming 2025 American Society of Clinical Onc ...